NCT04224350Unknown4 期
Multi Center Randomized Open-label Phase IV Study to Compare the Efficacy and Safety After Conversion to TacroBell SR Capsule or TacroBell Capsule in Renal Transplant Patients Undergoing Maintenance Therapy With Reference Tacrolimus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and Safety after conversion to TacroBell SR cap. or TacroBell cap. in patients who in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.
详细描述
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to TacroBell SR cap. or TacroBell cap. administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 years old(male or female)
- •Patients with eGFR (By CKD-EPI) ≥30mL/min/1.73m^2 and spot urine P/C ratio≤0.5 at screening test
- •Patients who are taking Tacrolimus twice a day for maintenance therapy and have Trough level of 3~10ng/ml
- •Agreement with written informed consent
排除标准
- •Patients who have transplanted organs other than kidney
- •Patients with acute rejection who have been clinically treated within the last month
- •Patients who have changed their administration of adjuvant immunosuppressants and corticosteroids within the last month (dose change, discontinuation, etc.)
- •Patients who have been diagnosed with cancer within the last 5 years (except skin cancer or thyroid cancer determined by the investigator that treatment has been completed)
- •Patients deemed inappropriate for screening due to severe digestive disorders at screening
- •Patients with severe systemic infections requiring treatment (transplantation may be possible after the infection is completely lost or controlled)
- •Patients with genetic problems of galactose-intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •If the following cases occur during screening
- •Treatment of active liver disease or increased one or more of the liver function tests (T-bilirubin, AST, ALT) levels more than three times the upper limit of normal range
- •Patients with WBC <2,500/mm^3, PLT <75,000/mm^3, ANC <1,300/μL
- •Patients who have experienced hypersensitivity reactions or serious abnormalities with medicines used in this clinical trial or with similar chemical structures (Tacrolimus, etc.)
- •Pregnant or lactating women
- •Patients of childbearing potential who do not agree to the proper use of contraception during the trial
- •Patients who received other investigational drugs within 4 weeks prior to consent of the document
- •Patients unable to participate in the clinical trial due to the judgment of other investigators
研究组 & 干预措施
Once-Daily Tacrolimus
Experimental
Experimental arm: TacroBell SR Cap.
干预措施: TacroBell SR cap. (Drug)
Twice a Day Tacrolimus
Active Comparator
Active Comparator arm: TacroBell Cap.
干预措施: Tacrolimus cap. (Drug)
结局指标
主要结局
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
时间窗: until 24 weeks
次要结局
- Survival rate of transplanted organ(until 24 weeks)
- eGFR(eGFR using CKD-EPI method) value(until 24 weeks)
- Serum-Cr value(until 24 weeks)
- Incidence of biopsy-confirmed acute rejection(TCMR, AMR)(until 24 weeks)
- Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy(until 24 weeks)
- Survival rate of Patients(until 24 weeks)
研究者
研究点 (1)
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